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Brief Title: Mylotarg and Ara-C in Untreated Patients Above 60 Years With AML and High-Risk MDS
Official Title: Phase II Evaluation of Gemtuzumab Ozogamicin in Combination With Cytarabine in Untreated Patients Above the Age of 60 Years With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome
Study ID: NCT00195000
Brief Summary: The purpose of this study is to find out how safe and effective the combination of Mylotarg in combination with cytarabine is in treating patients with Acute Myeloid Leukemia and advanced Myelodysplastic Syndrome over the age of 60 years.
Detailed Description: To evaluate the safety and efficacy of gemtuzumab ozogamicin in combination with cytarabine in inducing complete remission in patients with AML and advanced MDS over the age of 60 years. Patients eligible for treatment will receive the following: Mylotarg at 6 mg/m2 on day 1 as a 2 hour intravenous infusion Cytarabine at 100 mg/m2/day as a continuous intravenous infusion daily for 7 days
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Weill Medcial College of Cornell University, New York, New York, United States
Name: Eric Feldman, M.D.
Affiliation: Weill Medical College of Cornell University
Role: PRINCIPAL_INVESTIGATOR